Vonoprazan
As of the edition of 20 October 2026, Vonoprazan is a small molecule: marketed, first approved in 2014 (JP); acts on ATP4A and ATP4B; US protection ends in 2032.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Voquezna Dual Pak
- First approved
- 26 December 2014 (JP)
- Approvals on record
- 7 in 2 regions
- Holder of the most recent approval
- Phathom Pharmaceuticals; 2 holders in all
- Registered trials
- 113, 2 stopped early
- Disease areas
- Digestive system; Blood and lymph; Cancer; Immune system; Infections
US protection
US protection ends in 2032.
The last listed US exclusivity ends in 2032. The application that gives this date is held by Phathom Pharmaceuticals.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product9 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 9 listings behind itRequest access. Nothing is shown until you do.
Companies that need a new molecule because of this drug
1 company-target row on route B because of this drug.
Companies on route B for this drug
In the product1 company-target row is on route B because of Vonoprazan.
See the 1 company-target row on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 19 | 10 | 6 | 0 |
| Phase 1 | 23 | 21 | 0 | 1 |
| Phase 2 | 5 | 2 | 3 | 0 |
| Phase 3 | 34 | 31 | 3 | 0 |
| Phase 4 | 32 | 14 | 8 | 1 |
| All trials | 113 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Takeda | Applicant and Lead sponsor of trials | 2007 to now |
| Phathom Pharmaceuticals | Applicant and Lead sponsor of trials | 2019 to now |